Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTango Therapeutics, Inc.
About this trial
The goal of this interventional clinical trial is to learn about TNG260, a CoREST inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known STK11 mutation.
The main question\[s\] it aims to answer are:
* the recommended dose for Phase 2 * to evaluate the safety and tolerability of the combination therapy * to determine the pharmacokinetics of TNG260 * to evaluate the initial antineoplastic activity
Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.
Eligibility criteria
Qualifiers
Is ≥18 years of age at the time of signature of the main study ICF.
Has ECOG performance status of 0 or 1.
Has measurable disease based on RECIST v1.1.
All participants must have documented STK11 mutation in a solid tumor, which is identified through a validated analytical method
Disqualifiers
Known allergies, hypersensitivity, or intolerance to TNG260, PD-1 antibody or its excipients
Uncontrolled intercurrent illness that will limit compliance with the study requirements
Active infection requiring systemic therapy
Currently participating in or has planned participation in a study of another investigational agent or device
Trial design
Treatments tested in this trial
- TNG260
- Pembrolizumab
Treatment groups
126 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov